Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China

NCT03435406 | Unknown DMC

• 1 other identifier: CEE-HBV
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China

Conditions

Hepatopulmonary Syndrome

Keywords

Hepatitis B, Chronic; Cirrhosis; Hepatopulmonary Syndrome

Outcome Measures

Primary Outcomes (7)

• transthoracic contrast enhanced echocardiography (CEE)

  through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline

  During the operation

• arterial blood gas

  arterial blood gas analysis was performed through the radial artery.

  During the operation

• medical history

  The medical history was collected through consultation.

  During the operation

• acropachy

  acropachy was examined by inspection

  During the operation

• spider angioma

  spider angioma was examined by inspection

  During the operation

• liver palms

  liver palms was examined by inspection

  During the operation

• oxygen saturation

  oxygen saturation was examined by pulse oximetry

  During the operation

Secondary Outcomes (2)

• the content of bone morphogenetic protein (BMP9) in the patients with and without HPS

  4 to 6 months after the study completion

• micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS

  4 to 6 months after the study completion

Study Arms (2)

cirrhosis with HPS

Diagnosed as HPS

cirrhosis without HPS

Not Diagnosed as HPS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were selected with cirrhosis caused by HBV including Southwest Hospital, the first affiliated hospital of Chongqing Medical University, the People's hospital of Rongchang district and Qijiang District people's hospital

You may qualify if:

• Age: 18-80 years old;
• American association of anesthesiologists(ASA) score: I-III;
• Ability to comply with research programmes;
• Voluntary participation in the study;
• Has the history of HBV infection;
• No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)

You may not qualify if:

• Severe heart, lung, kidney disease coexisted;
• American association of anesthesiologists(ASA) score≥IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) \<70%, or FEV1 / FVC \<0.70;
• Mental state could not cooperate
• Absence of written informed consent.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Department of Anesthesiology, Southwest Hospital Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Hepatopulmonary Syndrome; Hepatitis B, Chronic; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lu K Zhi, PhD

  Department of Anesthesiology, Southwest Hospital Third Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Yi Bin, PhD

CONTACT

0086-02368754197; tang123a123123@163.com

tang xi, md

CONTACT

0086-18623198332; 12923699@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Institute of Anesthesiology, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: July 27, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

CN (1)